Tromboprofilaxis en COVID-19. Nuevas evidencias / COVID-19 thromboprophylaxis: New evidences

Recientes publicaciones han puesto en duda la eficacia de la utilización de dosis terapéuticas o intermedias de heparina de bajo peso molecular (HBPM) en pacientes COVID-19, especialmente en los pacientes más graves. Con el objetivo de actualizar estas recomendaciones se ha realizado una revisión no sistemática en las principales bases de datos médicas. Se seleccionaron un total de 14 ensayos clínicos aleatorizados, 14 metaanálisis y las recomendaciones de 12 sociedades científicas, estratificadas según el tipo de paciente (ambulatorio, hospitalizado, ingresado en cuidados críticos o post-alta). Se ha analizado la eficacia de HBPM y también de otras aproximaciones terapéuticas (rivaroxabán, apixabán, sulodexida, ácido acetilsalicílico e inhibidores P2Y12). Los hallazgos recomiendan utilizar dosis estándar de HBPM como tromboprofilaxis en los pacientes COVID-19 hospitalizados críticos y dosis terapéutica en hospitalizados no críticos si el riesgo de sangrado es bajo. En los pacientes ambulatorios y dados de alta del hospital podría utilizarse HBPM a dosis profiláctica si existen factores de riesgo trombótico y el riesgo hemorrágico es bajo. No se recomienda asociar antiagregantes plaquetarios a la HBPM salvo indicación previa.(AU)

Recent publications have questioned the efficacy of using therapeutic or intermediate doses of low molecular weight heparin (LMWH) in COVID-19 patients, especially in the most severe patients. In order to update these recommendations, a non-systematic review has been carried out in the main medical databases. A total of 14 randomized clinical trials, 14 meta-analyses and the recommendations of 12 scientific societies were selected, stratified according to the type of patient (outpatient, hospitalized, admitted to critical care or post-discharge). The efficacy of LMWH and other therapeutic approaches (rivaroxaban, apixaban, sulodexide, acetylsalicylic acid and P2Y12 inhibitors) has been analyzed. The findings recommend using standard doses of LMWH as thromboprophylaxis in critically hospitalized COVID-19 patients and therapeutic doses in non-critically hospitalized patients with low bleeding risk. In outpatients and those discharged from the hospital, LMWH could be used at a prophylactic dose if there are thrombotic risk factors, and the bleeding risk is low. It is not recommended to associate antiplatelet agents with LMWH unless previously indicated.(AU)

COVID-19 thromboprophylaxis. New evidence.

Recent publications have questioned the efficacy of using therapeutic or intermediate doses of low molecular weight heparin (LMWH) in COVID-19 patients, especially in the most severe patients. In order to update these recommendations, a non-systematic review has been carried out in the main medical databases. A total of 14 randomized clinical trials, 14 meta-analyses and the recommendations of 12 scientific societies were selected, stratified according to the type of patient (outpatient, hospitalized, admitted to critical care or post-discharge). The efficacy of LMWH and other therapeutic approaches (rivaroxaban, apixaban, sulodexide, acetylsalicylic acid and P2Y12 inhibitors) has been analyzed. The findings recommend using standard doses of LMWH as thromboprophylaxis in critically hospitalized COVID-19 patients and therapeutic doses in non-critically hospitalized patients if the risk of bleeding is low. In outpatients and those discharged from the hospital, LMWH could be used at a prophylactic dose if there are thrombotic risk factors, and the bleeding risk is low. It is not recommended to associate antiplatelet agents with LMWH unless previously indicated.

Eficacia de la tromboprofilaxis con heparina de bajo peso molecular en pacientes críticos con COVID-19: estudio observacional, prospectivo y multicéntrico / Effectiveness of thromboprophylaxis with low molecular weight heparin in critically ill patients with COVID-19. An observational prospective, multicenter study

Introducción: Los pacientes COVID-19 presentan una coagulopatía caracterizada por una elevada incidencia de complicaciones tromboembólicas. Ante la controversia existente sobre el manejo de la tromboprofilaxis, se llevó a cabo un estudio con el objetivo de analizar el efecto de las diferentes dosis de heparina de bajo peso molecular (HBPM) utilizadas en los pacientes críticos con COVID-19. Material y métodos: Se evaluaron datos del Reg-COVID-19. Se compararon 2 grupos de pacientes según la dosis de HBPM administrada: profilaxis y tratamiento. El objetivo primario fue determinar si había relación de la dosis de HBPM con la mortalidad. Los objetivos secundarios incluyeron la incidencia de eventos trombóticos y hemorrágicos, la duración de la estancia en la UCI, la ventilación mecánica invasiva y los parámetros trombóticos e inflamatorios. Resultados: Se analizaron datos de 720 pacientes, 258 en el grupo de profilaxis y 462 en el de tratamiento. La proteína C reactiva, la ventilación mecánica invasiva y el tratamiento con tocilizumab o corticosteroides se relacionaron con la elección de la dosis de HBPM. La incidencia de complicaciones hemorrágicas (66/720, 9,2%) y trombóticas (69/720, 9,6%) fue similar en ambos grupos, al igual que el curso temporal de los eventos trombóticos, que ocurrieron antes que los hemorrágicos (9 [3-18] y 12 [6-19] días, respectivamente). La mortalidad fue menor en el grupo de profilaxis (25,2 frente al 35,1%), pero al aplicar un modelo de ponderación de probabilidad inversa, no se encontraron diferencias entre los grupos. Conclusión: No se encontraron efectos beneficiosos ni perjudiciales relacionados con la administración de dosis profilácticas o terapéuticas de HBPM en pacientes críticos COVID-19, con una tasa similar de complicaciones hemorrágicas o trombóticas. A partir de estos resultados, consideramos que son necesarios más estudios para determinar el protocolo óptimo de tromboprofilaxis en estos pacientes.(AU)

Introduction: COVID-19 induces coagulopathy associated with an increase of thromboembolic events. Due to the lack of agreement on recommendations for thromboprophylactic management, the aim of this study was to study the dosages of LMWH used in critically ill COVID-19 patients assessing the effect on their outcome. Metohds: We evaluated data of the Reg-COVID19. According to LMWH dose two groups were analyzed: prophylaxis and treatment. Primary outcome was the relationship of LMWH dosage with mortality. Secondary outcomes included the incidence of thrombotic and bleeding events, length of ICU stay, invasive mechanical ventilation, and thrombotic and inflammatory parameters. Results: Data of 720 patients were analyzed, 258 in the prophylaxis group and 462 in the treatment group. C Reactive Protein, invasive mechanical ventilation, tocilizumab and corticosteroid treatments were related with the choice of LMWH dose. Hemorrhagic events (66/720, 9.2%) and thrombotic complications (69/720, 9.6%) were similar in both groups (P=.819 and P=.265), as was the time course of the thrombotic events, earlier than hemorrhagic ones (9 [3-18] and 12 [6-19] days respectively). Mortality was lower in prophylaxis group (25.2% versus 35.1%), but once an inverse probability weighting model was applied, we found no effect of LMWH dose. Conclusion: We found no benefit or harm with the administration of therapeutic or prophylactic LMWH dose in COVID19 critically ill patients. With a similar rate of hemorrhagic or thrombotic events, the LMWH dose had no influence on mortality. More studies are needed to determine the optimal thromboprophylaxis protocol for critically ill patients.(AU)

Effectiveness of thromboprophylaxis with low molecular weight heparin in critically ill patients with COVID-19. An observational prospective, multicenter study.

INTRODUCTION: COVID-19 induces coagulopathy associated with an increase of thromboembolic events. Due to the lack of agreement on recommendations for thromboprophylactic management, the aim of this study was to study the dosages of LMWH used in critically ill COVID-19 patients assessing the effect on their outcome. METHODS: We evaluated data of the Reg-COVID19. According to LMWH dose two groups were analyzed: prophylaxis and treatment. Primary outcome was the relationship of LMWH dosage with mortality. Secondary outcomes included the incidence of thrombotic and bleeding events, length of ICU stay, invasive mechanical ventilation, and thrombotic and inflammatory parameters. RESULTS: Data of 720 patients were analyzed, 258 in the prophylaxis group and 462 in the treatment group. C Reactive Protein, invasive mechanical ventilation, tocilizumab and corticosteroid treatments were related with the choice of LMWH dose. Hemorrhagic events (66/720, 9.2%) and thrombotic complications (69/720, 9.6%) were similar in both groups (p = .819 and p = .265), as was the time course of the thrombotic events, earlier than hemorrhagic ones (9 [3-18] and 12 [6-19] days respectively). Mortality was lower in prophylaxis group (25.2% versus 35.1%), but once an inverse probability weighting model was applied, we found no effect of LMWH dose. CONCLUSION: We found no benefit or harm with the administration of therapeutic or prophylactic LMWH dose in COVID19 critically ill patients. With a similar rate of hemorrhagic or thrombotic events, the LMWH dose had no influence on mortality. More studies are needed to determine the optimal thromboprophylaxis protocol for critically ill patients.

[Effectiveness of thromboprophylaxis with low molecular weight heparin in critically ill patients with COVID-19. An observational prospective, multicenter study]. / Eficacia de la tromboprofilaxis con heparina de bajo peso molecular en pacientes críticos con COVID-19: estudio observacional, prospectivo y multicéntrico.

Introduction: COVID-19 induces coagulopathy associated with an increase of thromboembolic events. Due to the lack of agreement on recommendations for thromboprophylactic management, the aim of this study was to study the dosages of LMWH used in critically ill COVID-19 patients assessing the effect on their outcome. Metohds: We evaluated data of the Reg-COVID19. According to LMWH dose two groups were analyzed: prophylaxis and treatment. Primary outcome was the relationship of LMWH dosage with mortality. Secondary outcomes included the incidence of thrombotic and bleeding events, length of ICU stay, invasive mechanical ventilation, and thrombotic and inflammatory parameters. Results: Data of 720 patients were analyzed, 258 in the prophylaxis group and 462 in the treatment group. C Reactive Protein, invasive mechanical ventilation, tocilizumab and corticosteroid treatments were related with the choice of LMWH dose. Hemorrhagic events (66/720, 9.2%) and thrombotic complications (69/720, 9.6%) were similar in both groups (P=.819 and P=.265), as was the time course of the thrombotic events, earlier than hemorrhagic ones (9 [3-18] and 12 [6-19] days respectively). Mortality was lower in prophylaxis group (25.2% versus 35.1%), but once an inverse probability weighting model was applied, we found no effect of LMWH dose. Conclusion: We found no benefit or harm with the administration of therapeutic or prophylactic LMWH dose in COVID19 critically ill patients. With a similar rate of hemorrhagic or thrombotic events, the LMWH dose had no influence on mortality. More studies are needed to determine the optimal thromboprophylaxis protocol for critically ill patients.

Recomendaciones de consenso SEDAR-SEMICYUC sobre el manejo de las alteraciones de la hemostasia en los pacientes graves con infección por COVID-19 / SEDAR-SEMICYUC consensus recommendations on the management of haemostasis disorders in severely ill patients with COVID-19 infection

La infección por el coronavirus SARS-CoV-2, causante de la enfermedad denominada COVID-19, provoca alteraciones fundamentalmente en el sistema respiratorio. En los pacientes graves, con frecuencia la enfermedad evoluciona a un síndrome de distrés respiratorio agudo que puede predisponer a los pacientes a un estado de hipercoagulabilidad, con trombosis tanto a nivel venoso como arterial. Esta predisposición presenta una fisiopatología multifactorial, relacionada tanto con la hipoxia como con el grave proceso inflamatorio ligado a esta patología, además de los factores trombóticos adicionales presentes en muchos de los pacientes.Ante la necesidad de optimizar el manejo de la hipercoagulabilidad, los grupos de trabajo de las sociedades científicas de Anestesiología-Reanimación y Terapéutica del Dolor (SEDAR) y de Medicina Intensiva, Crítica y de Unidades Coronarias (SEMICYUC) han desarrollado un consenso para establecer unas pautas de actuación frente a las alteraciones de la hemostasia observadas en los pacientes graves COVID-19. Estas recomendaciones incluyen la profilaxis de la enfermedad tromboembólica venosa en pacientes graves y en el periparto, el manejo de los pacientes en tratamiento crónico con fármacos antiagregantes o anticoagulantes, de las complicaciones hemorrágicas en la evolución de la enfermedad y de la interpretación de las alteraciones generales de la hemostasia

The infection by the coronavirus SARS-CoV-2, which causes the disease called COVID-19, mainly causes alterations in the respiratory system. In severely ill patients, the disease often evolves into an acute respiratory distress syndrome that can predispose patients to a state of hypercoagulability, with thrombosis at both venous and arterial levels. This predisposition presents a multifactorial physiopathology, related to hypoxia as well as to the severe inflammatory process linked to this pathology, including the additional thrombotic factors present in many of the patients. In view of the need to optimise the management of hypercoagulability, the working groups of the Scientific Societies of Anaesthesiology-Resuscitation and Pain Therapy (SEDAR) and of Intensive, Critical Care Medicine and Coronary Units (SEMICYUC) have developed a consensus to establish guidelines for actions to be taken against alterations in haemostasis observed in severely ill patients with COVID-19. These recommendations include prophylaxis of venous thromboembolic disease in these patients, and in the peripartum, management of patients on long-term antiplatelet or anticoagulant treatment, bleeding complications in the course of the disease, and the interpretation of general alterations in haemostasis

SEDAR-SEMICYUC consensus recommendations on the management of haemostasis disorders in severely ill patients with COVID-19 infection. / Recomendaciones de consenso SEDAR-SEMICYUC sobre el manejo de las alteraciones de la hemostasia en los pacientes graves con infección por COVID-19.

The infection by the coronavirus SARS-CoV-2, which causes the disease called COVID-19, mainly causes alterations in the respiratory system. In severely ill patients, the disease often evolves into an acute respiratory distress syndrome that can predispose patients to a state of hypercoagulability, with thrombosis at both venous and arterial levels. This predisposition presents a multifactorial physiopathology, related to hypoxia as well as to the severe inflammatory process linked to this pathology, including the additional thrombotic factors present in many of the patients. In view of the need to optimise the management of hypercoagulability, the working groups of the Scientific Societies of Anaesthesiology-Resuscitation and Pain Therapy (SEDAR) and of Intensive, Critical Care Medicine and Coronary Units (SEMICYUC) have developed a consensus to establish guidelines for actions to be taken against alterations in haemostasis observed in severely ill patients with COVID-19. These recommendations include prophylaxis of venous thromboembolic disease in these patients, and in the peripartum, management of patients on long-term antiplatelet or anticoagulant treatment, bleeding complications in the course of the disease, and the interpretation of general alterations in haemostasis.

Estado actual de la fluidoterapia en el paciente quirúrgico en nuestro medio. A propósito del estudio Fluid Day / Fluid therapy in the surgical patient in our environment. Reporting on the Fluid Day Study

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Algoritmo de reversión para los pacientes anticoagulados con dabigatrán en cirugía urgente / Reversion algorithm for patients anticoagulated with dabigatran in urgent surgery

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Recomendaciones de manejo perioperatorio de antiagregantes plaquetarios en cirugía no cardíaca. Grupo de trabajo de la Sección de Hemostasia, Medicina Transfusional y Fluidoterapia de la Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor (SEDAR). Actualización de la Guía de práctica clínica 2018 / Recommendations for perioperative antiplatelet treatment in non-cardiac surgery. Working Group of the Spanish Society of Anaesthesiology-Resuscitation and Pain Therapy, Division of Haemostasis, Transfusion Medicine, and Perioperative Fluid Therapy. Update of the Clinical practice guide 2018

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Manejo perioperatorio de los anticoagulantes orales directos en cirugía urgente y sangrado. Monitorización y tratamiento hemostático / Perioperative management of direct oral anticoagulant in emergency surgery and bleeding. Haemostasis monitoring and treatment

Existe un amplio consenso sobre el manejo perioperatorio de los pacientes tratados con los nuevos anticoagulantes orales directos (dabigatrán, ribaroxabán y apixabán) en cirugía programada. Por el contrario, en la actualidad no existe este nivel de acuerdo en cirugía urgente, especialmente en el paciente sangrante. Por este motivo, se ha realizado una revisión bibliográfica a través del buscador PubMed en la base de datos MEDLINE de los artículos publicados entre 2000-2014 referidos a los términos «monitorización» y «reversión» de los fármacos mencionados. Guías de práctica clínica, revisiones sistemáticas, revisiones y artículos sobre la materia se incluyeron en la búsqueda. Se verifica un limitado papel de los test rutinarios de coagulación (tiempo de protrombina y tiempo parcial de tromboplastina activado) en el manejo perioperatorio de estos pacientes. Así mismo, muestran la ausencia de antídotos específicos, aunque plantean la posibilidad de usar concentrado de complejo protrombínico y factor vii activado recombinante en la reversión urgente de su efecto anticoagulante (AU)

There is an almost unanimous consensus on the management of the direct new oral anticoagulants, dabigatran, rivaroxaban, and apixaban in elective surgery. However, this general consensus does not exist in relation with the direct new oral anticoagulants use in emergency surgery, especially in the bleeding patient. For this reason, a literature review was performed using the MEDLINE-PubMed. An analysis was made of the journal articles, reviews, systematic reviews, and practices guidelines published between 2000 and 2014 using the terms “monitoring” and “reversal”. From this review, it was shown that the routine tests of blood coagulation, such as the prothrombin time and activated partial thromboplastin time, have a limited efficacy in the perioperative control of blood coagulation in these patients. There is currently no antidote to reverse the effects of these drugs, although the possibility of using concentrated prothrombin complex and recombinant activated factor vii has been suggested for the urgent reversal of the anticoagulant effect (AU)

[Perioperative management of direct oral anticoagulant in emergency surgery and bleeding. Haemostasis monitoring and treatment]. / Manejo perioperatorio de los anticoagulantes orales directos en cirugía urgente y sangrado. Monitorización y tratamiento hemostático.

There is an almost unanimous consensus on the management of the direct new oral anticoagulants, dabigatran, rivaroxaban, and apixaban in elective surgery. However, this general consensus does not exist in relation with the direct new oral anticoagulants use in emergency surgery, especially in the bleeding patient. For this reason, a literature review was performed using the MEDLINE-PubMed. An analysis was made of the journal articles, reviews, systematic reviews, and practices guidelines published between 2000 and 2014 using the terms "monitoring" and "reversal". From this review, it was shown that the routine tests of blood coagulation, such as the prothrombin time and activated partial thromboplastin time, have a limited efficacy in the perioperative control of blood coagulation in these patients. There is currently no antidote to reverse the effects of these drugs, although the possibility of using concentrated prothrombin complex and recombinant activated factor vii has been suggested for the urgent reversal of the anticoagulant effect.

The perioperative management of new direct oral anticoagulants: a question without answers.

New direct oral anticoagulant agents (DOAC) are currently licensed for thromboprophylaxis after hip and knee arthroplasty and for long-term prevention of thromboembolic events in non-valvular atrial fibrillation as well as treatment and secondary prophylaxis of venous thromboembolism. Some other medical indications are emerging. Thus, anaesthesiologists are increasingly likely to encounter patients on these drugs who need elective or emergency surgery. Due to the lack of experience and data, the management of DOAC in the perioperative period is controversial. In this article, we review available information and recommendations regarding the periprocedural management of the currently most clinically developed DOAC, apixaban, dabigatran, and rivaroxaban. We discuss two trends of managing patients on DOAC for elective surgery. The first is stopping the DOAC 1-5 days before surgery (depending on the drug, patient and bleeding risk) without bridging. The second is stopping the DOAC 5 days preoperatively and bridging with low-molecular-weight heparin. The management of patients on DOAC needing emergency surgery is also reviewed. As no data exist for the use of haemostatic products for the reversal of the anticoagulant effect in these cases, rescue treatment recommendations are proposed.